Lymphoma Clinical Trial
Official title:
A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults
Verified date | April 2024 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
Status | Completed |
Enrollment | 733 |
Est. completion date | October 31, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - INCLUSION CRITERIA FOR PHYSICIANS - Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study - INCLUSION CRITERIA FOR PATIENTS - Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed - Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met. *Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (>50%) will be allowed. - Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits - Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy - Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit. If the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll. - Participant has adequate understanding of the English language Exclusion Criteria: - EXCLUSION CRITERIA FOR PATIENTS - Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible - Presence of symptomatic brain metastases at time of study consent process. Patients with a history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
United States | Columbus NCORP | Columbus | Ohio |
United States | Geisinger Cancer Institute NCORP | Danville | Pennsylvania |
United States | Dayton NCORP | Dayton | Ohio |
United States | Heartland NCORP | Decatur | Illinois |
United States | City of Hope | Duarte | California |
United States | Cancer Research Consortium of West Michigan | Grand Rapids | Michigan |
United States | NCORP of the Carolinas | Greenville | South Carolina |
United States | Hawaii MU-NCORP | Honolulu | Hawaii |
United States | Kansas City NCORP | Kansas City | Missouri |
United States | North Shore LIJ Health System NCORP | Lake Success | New York |
United States | Nevada NCORP | Las Vegas | Nevada |
United States | Wisconsin NCORP | Marshfield | Wisconsin |
United States | Aurora NCORP | Milwaukee | Wisconsin |
United States | Metro Minnesota NCORP | Minneapolis | Minnesota |
United States | Gulf South MU-NCORP | New Orleans | Louisiana |
United States | Delaware/Christiana Care NCORP | Newark | Delaware |
United States | Pacific Cancer Research Consortium Ncorp | Portland | Oregon |
United States | Kansas City NCORP | Prairie Village | Kansas |
United States | University of Rochester | Rochester | New York |
United States | Northwest NCORP | Tacoma | Washington |
United States | Wichita NCORP | Wichita | Kansas |
United States | Southeast Clinical Oncology Research Program | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Supriya Mohile | City of Hope National Medical Center, National Cancer Institute (NCI), University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Experienced Any Grade 3-5 Toxicity | Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0. | 3 months | |
Secondary | Patient Survival at 6 Months | Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method. | 6 months | |
Secondary | Reduced Dose Intensity | Proportion of patients with reduced dose intensity in cycle 1. | 4-6 weeks | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | The type and frequency of GA-driven recommendations implemented for older patients with impaired physical performance and starting a new treatment regimen for advanced cancer. Physical Performance measures included: Timed Up and Go, Short Physical Performance Battery, Falls History, and OARS Physical Health. | Baseline | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | The type and frequency of GA-driven recommendations implemented for older patients with impaired functional status and starting a new treatment regimen for advanced cancer. Functional Status measures included: Activities of Daily Living and Instrumental Activities of Daily Living. | Baseline | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | The type and frequency of GA-driven recommendations implemented for older patients with impaired comorbidities and starting a new treatment regimen for advanced cancer. Comorbidity measure included: OARS Comorbidity. | Baseline | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Cognition. | The type and frequency of GA-driven recommendations implemented for older patients with impaired cognition and starting a new treatment regimen for advanced cancer. Cognition measures included: Blessed Orientation Memory Concentration and Mini Cog assessments. | Baseline | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | The type and frequency of GA-driven recommendations implemented for older patients with impaired nutrition and starting a new treatment regimen for advanced cancer. Nutrition measures included: Body Mass Index, Weight Loss, and Mini Nutrition Assessment. | Baseline | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Social Support. | The type and frequency of GA-driven recommendations implemented for older patients with impaired social support and starting a new treatment regimen for advanced cancer. Social Support measure included: OARS Medical Social Support. | Baseline | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | The type and frequency of GA-driven recommendations implemented for older patients with impaired polypharmacy and starting a new treatment regimen for advanced cancer. Polypharmacy measure included: medication review. | Baseline | |
Secondary | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | The type and frequency of GA-driven recommendations implemented for older patients with impaired psychological status and starting a new treatment regimen for advanced cancer. Psychological measures included: Geriatric Depression Scale and Generalized Anxiety Disorder - 7 item scale. | Baseline |
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